Recall of defective drugs: DRAP seeks input of stakeholders on guidelines

ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) in line with World Health Organization (WHO) guidelines has sought stakeholders’ input on the revision of guidelines on the recall of defective therapeutic goods.

In a 52-page draft invitation released here on Wednesday, the DRAP said that the authority is revising the guidelines on recalls and rapid alerts of defective therapeutic goods, which were first published in 2021andwere based on the feedback from stakeholders and the recommendations from the WHO.

The guidelines provide a comprehensive framework for reporting, investigating, and recalling suspected defective therapeutic goods products and apply to the therapeutic goods industry and supply chain, healthcare professionals, patients, sponsors of clinical trials, and regulatory staff.

The guidelines aim to provide recommendations and explain the procedures to be adopted by the DRAP and the pharmaceutical industry for the effective removal of defective therapeutic goods from the market that may cause harm to the consumer and to safeguard public health.

By adhering to these guidelines, the licensees and the DRAP can ensure a timely, coordinated, and transparent response to any defective therapeutic goods incidents and thus protect the health and safety of the public and the animals.

The authority has stated the following main objectives of the revision: (i) Update the procedures for recalls and related actions for defective therapeutic goods; (ii) Adopt a uniform and consistent approach to conducting recalls in Pakistan; (iii) Incorporate the best practices and lessons learned from the consultative workshop on recalls and rapid alerts held by DRAP; (iv) Enhance the communication and coordination among the manufacturers, importers, suppliers, and DRAP in conducting recalls; and (v) Strengthen the monitoring and evaluation of the recall outcomes and follow-up actions

The DARP has invited all stakeholders to review the draft revised guidelines and provide comments and suggestions.

Copyright Business Recorder, 2024